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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – Non-MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

About Immunology

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

The Clinical Science group within Translational Medicine is searching for the best talent for a Manager, Clinical Science, Immunology, Translational Science & Medicine to be based in Spring House, PA.

The TM - Clinical Science group works together with others in TSM (e.g. Biomarkers, Digital Health, etc.) to design and conduct early clinical development and experimental medicine studies to enable program strategy. Johnson and Johnson Immunology Innovative Medicine has a history of bringing life-changing therapies to patients with immune-mediated diseases. The TSM group will provide the key learnings/insights on the next wave of novel therapies for these patients. We are looking for someone with a BS, MS, PharmD, PhD or research nursing (RN) background, industry experience, and preferably a scientific background in Immunology or related field, to join this collaborative research and development group, and help us bring these new therapies to patients.

The primary focus of this Manager, Clinical Scientist position within Immunology Translational Science and Medicine (TSM) is to serve as a key member of early development clinical trial teams, partnering and leading the team designing and executing clinical studies outlined in the asset development plan (ADP). At its core, this work is a deep collaboration between Disease Area experts, Translational Science (Biomarker) experts, Immunologic Pathway experts and many other essential development functions. The Clinical Scientist partners with Global Development Operations (GDO) and the entire Trial Team to efficiently and effectively operationalize the studies.

The Clinical Scientist Manager functions in the role of a Study Responsible Scientist (SRS) on cross functional trial teams, and workgroups, is competent in the role and with minimal supervision, leads the team designing Phase 0, 1 and 2a clinical studies. In addition, the Clinical Scientist may also contribute to the scientific and strategic content of the asset development plan or contribute to the scientific evaluation of new disease pathways and targets, helping determine the best disease indications for the project. The Clinical Scientist will work closely with cross functional partners to implement translational science and digital health strategies or sub-studies in all phases of clinical development.

Responsibilities include:

• Collaborating with other team members within TSM (e.g. working closely with SRP), supporting the design, execution, analysis, and presentation of TSM studies.
• Collaborating with Discovery Research, Translational Science, Clinical Pharmacology and Pharmacometrics, Global Development Operations (GDO), and others to implement biomarker and translational research plans for early development programs.
• In collaboration with Disease Area experts and Program leads, may be asked to contribute to the development of the scientific background and strategic content of the asset development plan.
• Supporting the GDO group with trial set up, conduct, and monitoring, and database locks.
• Ensuring that study conduct adheres to Good Clinical Practices, International Conference of Harmony (ICH) guidelines, and standard operating procedures.
• In collaboration with GDO, identifying clinical sites and CROs/Vendors that will participate in TSM trials.
• Support preparation of the clinical content of drug safety documents and reports such as the investigator brochures, DSURs, and other regulatory response documents.
• Interacting with staff responsible for the design, set-up, execution, analysis and reporting of these studies.
• Reviewing incoming data from the study for accuracy and completeness.
• Participating in the review and interpretation of clinical trial data to enable timely internal decision-making and external communication with investigators and regulatory agencies.
• Participating in the preparation and assuring the accuracy of the clinical study reports as well as any external publications.
• Reporting the status of clinical trials to management.

Qualifications

• BS, MS, PharmD, PhD or RN preferably with a scientific background in Immunology or a related field, and 4-8 years industry experience is required.
• Previous clinical development experience is required, experience with innovative trial designs (adaptive, platform, basket, combination therapy) preferred.
• Experience with Ph 0, 1 and 2a studies in immunology indications is preferred.
• Ability to survey and interpret the scientific literature related to the assigned projects is required.
• Strong organizational skills and the ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the business.
• Good interpersonal skills and the ability to advise, persuade, and negotiate with colleagues in a supportive and encouraging fashion.
• Excellent written and verbal English communication skills.
• The ability to work in a global matrix organization with cross-functional teams is required.
• Willingness and ability to travel including international travel is required.
• Proficient with Microsoft Office applications, and other systems and tools used in early clinical development.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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